Policy & Regulation
LISCure Biosciences' LB-P8 receives US FDA Fast Track designation
1 April 2024 -

LISCure Biosciences, a South Korea-based clinical-stage biopharmaceutical company, announced on Friday that it has received Fast Track designation from the US Food and Drug Administration (FDA) for LB-P8, its investigational drug for the treatment of primary sclerosing cholangitis (PSC).

PSC is a rare, chronic, cholestatic liver disease with significant unmet medical needs as there are no approved drugs available to treat it.

LB-P8 is undergoing assessment in a Phase 2 study in patients with PSC. According to LISCure, it is the only live biotherapeutic product currently reported to be in clinical development to address the requirement of individuals with PSC.

The company is carrying out a Phase 2 study in multiple sites across the US and Europe. Preliminary results are expected to be revealed in early 2025. Based on the results, the company says that it will make maximum use of accelerated programmes to bring LB-P8 to market as quickly as possible.

LB-P8 is also being developed for metabolic dysfunction-associated steatohepatitis (MASH).